Disposable surgical intervention guides, methods, and kits

ABSTRACT

The present invention relates to devices, kits, and methods for planning and carrying out surgical interventions and/or radiographic imaging, particularly dental implant radiographic imaging or surgical interventions.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is claims priority to U.S. Provisional Application No.62/096,823, filed Dec. 24, 2014. This provisional application isincorporated herein by reference.

TECHNICAL FIELD

The present invention relates to devices, kits, and methods for planningand carrying out surgical interventions and/or radiographic imaging,particularly dental implant radiographic imaging or surgicalinterventions.

BACKGROUND OF THE INVENTION

In dental surgery, a missing tooth is often replaced by a prosthetictooth, being anchored to the maxillary or mandibular bone of a patientby means of a dental implant previously inserted into said bone. Theinstallation of dental implants requires an osteotomy to be carried out,which involves the drilling of a bore hole into the maxillary ormandibular bone to create a seat for the successive implant insertion.The bore placement and orientation must be determined carefully beforethe osteotomy can be carried out. It is important for a successfulsurgery to ensure that the bore is sufficient to hold and maintain aprosthetic device and that the operation does not damage unintended oradjacent portions of the anatomy of the subject, such as the root of anadjacent tooth or nerves of the lower jaw or maxillary sinus of theupper or lower jaw. Generally, it is recommended that the implant isinstalled at a stable and precise location and angle and to a precisedepth. Further, it is important that the angle created for theprosthetic is correct from a physiological point of view and is inharmony with the other portions of the anatomy of the subject.

Current methods for preparing for an implantation intervention requiremultiple independent sessions with the dentist and radiologist, often indifferent locations, prior to carrying out the procedure as well as afair amount of work on the side of the dentist to prepare a guide modelor stent. In addition, current methods require the use of the naked eyeof the dentist to ensure proper angulation and depth of the implant borebased on the guide model and information from radiographic scans, thusrequiring a highly skilled and trained dentist or surgeon.

SUMMARY OF THE INVENTION

In frequent embodiments, a modular surgical or drill guide assembly isprovided, comprising a deformable casting medium defining an opentreatment area; and a foundation plate or radiographic guidecircumscribing the open treatment area, wherein the foundation plate andthe deformable medium are comprised of different materials, and thefoundation plate is positioned in contact with the deformable medium.Often, the modular drill guide assembly further comprises a sensor arraycomprising two or more sensors affixed to the foundation plate. Alsooften, a guide base is affixed to the foundation plate, wherein theguide base comprises a base opening. The sensors often compriseelectromagnetic sensors. In certain embodiments, the foundation platecomprises an open arched material defined by an upper portion and alower portion, wherein the lower portion is configured to be situated ator below a gumline in the mouth of a subject when positioned on thesubject, and the upper portion is configured to be situated at or abovethe top of the teeth of the subject. The deformable casting mediumfrequently comprises a putty, a paste, or an epoxy. Often, thedeformable casting medium comprises an impression material.

The foundation plate often further comprises laterally extending feet,wherein the laterally extending feet are embedded within the deformablecasting medium. Also, the foundation plate often further comprises twoor more fiducial markers. Frequently, the foundation plate comprisesfour fiducial markers.

The modular drill guide assembly often further comprises a sensor arraycomprising two or more sensors affixed to the foundation plate, whereinthe sensors are positioned at or about at the gumline of the subject.Often the sensor array comprises 4 or 8 sensors. The term “affixed” hererefers to permanently or releasably attached. Often the sensors arepositioned between the upper and lower portions of the foundation plate.Also often, the sensors are positioned below the top of the teeth of asubject. The sensor array comprises a certain embodiment of a manner ofsensor placement. In certain embodiments, the sensors comprise pairedsensors. Often, the sensor array (whether it comprises paired sensors orotherwise) comprises 3, 4, 6, 8, 9, 12, 15, or 16 sensors. The sensorarray frequently further comprises a wireless transponder. The sensorarray itself often comprises a separate component attached to thefoundation plate. In certain embodiments the sensor array is comprisedin the foundation plate, optionally as a single component.

In frequent embodiments, the modular drill guide assembly furthercomprises a guide collar affixed to the guide base, wherein the guidecollar comprises a central opening coaxially situated with the baseopening. The central opening is often configured to mate with a drillbit sleeve. The guide base often comprises a separate component attachedto the foundation plate.

In certain embodiments, a foundation plate for conducting a surgicaloperation is provided, comprising an open arched material defined by afirst and second upper portion perpendicularly situated to a first andsecond lower portion, and two or more fiducial markers, each upperportion having a pair of bilateral sloping arms connecting the first andsecond upper portions to the first and second lower portions, whereineach of the lower portions comprises a laterally extending foot prong.Often, at least one of the pair of bilateral sloping arms comprises anattachment point for a secondary device. Also often, each of the two ofmore fiducial markers is comprised in the first and/or second lowerportion. In certain embodiments, at least one of the lower portionscomprises an attachment point for a guide collar or a placementapparatus. The placement apparatus often comprises forceps or fingers.At least one of the lower portions often comprises an attachment pointfor a secondary device. And, the secondary device often comprises aguide base or a sensor array. The laterally extending foot prong isfrequently operable to be inserted into a deformable casting medium andsupport the foundation plate in contact with the deformable castingmedium. In certain embodiments, the open arched material defines an opensurgical area that is unimpeded both (a) vertically; and (b) laterally,parallel to the first and second upper portions and above the lowerportions. The fiducial markers are most frequently visible in a CT scan.In certain frequent embodiments, the foundation plate comprises adirectional mark that indicates the intended orientation of thefoundation relative to the mouth of a subject. Often, the directionalmark is provided on one or both of the first and second upper portions.In certain embodiments, at least one of the pair of bilateral slopingarms comprises a sensor array attachment point. Often, each of thebilateral sloping arms of the first and second upper portions comprisesa sensor array attachment point, wherein at least one of the sensorarray attachment points is configured in a different size, shape ororientation than at least one other sensor array attachment point.

In certain frequent embodiments, a sensor array is provided comprising:an open arched material defined by a first and second upper portionperpendicularly situated to a lower portion, each upper portion having apair of bilateral sloping arms, wherein the lower portion is connectedto a bilateral sloping arm of each of upper portions; a sensor comprisedin the lower portion; a transponder in communication with the sensor andconfigured to transmit data received by the sensor to a remoteprocessor. Often, the sensor array further comprises a bisected secondlower portion, wherein each portion of the bisected second lower portionis connected to one of the pair of bilateral sloping arms of each of thefirst and second upper portions. The sensor array also often furthercomprising a peg situated on the lower portion or on one or more of thesloping arms, wherein the peg is adapted to mate with an attachmentpoint of a foundation plate. The transponder itself often comprises aBluetooth transponder and/or is powered with a low power battery. Thelow power battery often provides a short duration of power to thetransponder. In certain embodiments, the transponder is removablyattachable or attached to the sensor array, or is attachable or attachedto the sensor array.

The sensor frequently comprises 3 or more sensors, 4 sensors, between 4to 8 sensors, 8 sensors, or more than 8 sensors. In certain embodiments,each of the 3 or more sensors is spatially situated in a pre-determinedgeometric orientation on the sensor array. In certain embodiments, eachof the 4 sensors is spatially situated in a pre-determined geometricorientation on the sensor array. In certain frequent embodiments,multiple sensors are paired in a vertical or horizontal plane. Incertain embodiments at least one sensor is placed vertically above atleast one other sensor. In certain embodiments, two or more sensor pairsare provided, wherein each sensor of the pair is positioned in the samedirectional plane. This geometric orientation frequently comprises atriangle, square, or rectangle, or another pre-determined shape ororientation. Often, the sensors are arranged so that they surround anopen treatment area or implant site when the sensor array is positionedon a subject. The exemplary open arched material of the sensor oftendefines an open surgical area that is unimpeded both (a) vertically; and(b) laterally from one side, parallel to the first and second upperportions. The sensor of the sensor array frequently comprises anelectromagnetic, piezoelectric, or optic sensor.

In certain embodiments, the sensor comprises two or more paired sensors.Often, the sensor array (whether it comprises paired sensors orotherwise) comprises 3, 4, 6, 8, 9, 12, 15, or 16 sensors.

Though not wishing to be bound by any particular theory, presence anduse of multiple sensors arranged in a vertical plane relative toone-another provides enhanced accuracy or visual granularity regardingone or more of drill bit or other surgical device depth, vertical speed,tilt angle, or offset angle. Often this vertical plane arrangement ofsensors is referred to herein as “paired” or “pairing,” though it mayinvolve two or more (e.g., 3, 4, 5, 6, etc.) vertically arrangedsensors. In embodiments utilizing a paired arrangement, often multipleadditional horizontally-arranged sensors are provided as describedherein that may also have a paired arrangement.

In certain embodiments, an angle setting apparatus is provided,comprising: an angle arm moveable along an arced path and configured tohold a collar pin; a swivel plate comprising lingual and buccal indicia;and a guide base holder configured to contain a guide base. The arcedpath of the apparatus often defines an offset angle, and the swivelplate is often rotatable to define a tilt angle. The angle settingapparatus often further comprises a digital readout, providing anindication of an offset angle and a tilt angle defined by the arced pathand swivel plate. The angle setting apparatus frequently furthercomprises a guide collar, a collar pin, and a guide base, wherein theguide base is contained in the guide base holder, and the collar pin isheld in the angle arm in communication with the guide collar positionedon the guide base. Moreover, the angle setting apparatus often furthercomprises a locking knob in communication with the angle arm and/or theswivel plate to lock the angle arm and/or the swivel plate into apredetermined orientation.

In certain embodiments, a disposable surgical or drill guide kit isprovided, comprising: (a) a deformable casting medium; (b) a foundationplate; and (c) a secondary apparatus comprising at least one of one orboth of: (i) a sensor array; or (ii) a guide platform comprising a guidebase affixed with a guide collar. In other embodiments, a disposablesurgical or drill guide kit is provided, comprising: (a) a foundationplate configured to embed within a deformable casting medium; and (b) asecondary apparatus comprising at least one or both of: (i) a sensorarray; or (ii) a guide platform comprising a guide base affixed with aguide collar.

In other frequent embodiments, methods are provided for preparing for adental implant intervention, comprising: forming a registration device,comprising the steps of: (a) applying a deformable casting medium to ananatomical region of a subject; (b) introducing a foundation plate tothe deformable casting medium, wherein at least a portion of thefoundation plate is embedded into the deformable casting medium; (c)adjusting the foundation plate within the deformable casting mediumrelative to an implant site; and (d) permitting the deformable castingmedium to harden; obtaining radiological scan information of theregistration device positioned on the subject within a computer system;and creating a surgical intervention plan comprising a tilt angle, anoffset angle, and a depth limitation using the radiological scaninformation.

In other frequent embodiments, methods are provided for conducting adental implant intervention, comprising: applying a registration deviceto an implant site of a subject; affixing a secondary device to theregistration device, wherein the secondary device comprises at least oneor both of: (a) a sensor array; or (b) a guide platform comprising aguide base affixed with a guide collar introducing a drill bit throughthe registration device into contact with the implant site; guiding orconfirming an orientation and a travel distance of the drill bit in theimplant site using (i) the guide platform, and/or (ii) information aboutthe orientation and travel distance of the drill bit obtained from thesensor array. Often, a surgical intervention plan is confirmed prior tointroducing the drill bit through the registration device. Also often,the information about the orientation and travel distance of the drillbit comprises real-time information and is displayed on a computer userinterface or display. In the methods described herein, the real-timeinformation is frequently displayed together with radiologicalinformation of the implant site and registration device.

In certain embodiments, a surgical or drill guide device is providedcomprising one or more electromagnetic sensors, wherein the surgical ordrill guide is operable to position the one or more sensors at about thegumline of a subject when the surgical guide is removably positioned atan implant site on the subject. In certain embodiments, the one or moreelectromagnetic sensors comprise paired sensors. In certain embodiments,a surgical or drill guide device is provided comprising a physicalguide, wherein the drill guide is operable to position the physicalguide at about the gumline of a subject when the surgical guide isremovably positioned at an implant site on the subject. In certainembodiments, a hybrid surgical or drill guide device is providedcomprising one or more electromagnetic sensors and a physical guide,wherein the drill guide is operable to position the physical guide andthe one or more electromagnetic sensors at about the gumline of asubject when the surgical guide is removably positioned at an implantsite on the subject. In certain embodiments, a radiographic guide deviceis provided comprising one or more fiducials, wherein the radiographicguide is operable to position the fiducials at about the gumline of asubject when the radiographic guide is removably positioned at animplant site on the subject. In frequent embodiments, any of thesedevices is disposable. In related embodiments, kits are providedcomprising any one or more of these devices.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts an exemplary molding tray together with an amount ofdeformable casting medium.

FIG. 2 depicts an exemplary molding tray containing deformable castingmedium.

FIG. 3 depicts an exemplary molding tray positioned above an implantsite of a model anatomy.

FIG. 4 depicts deformable casting medium formed around the teeth of amodel anatomy, surrounding an implant site.

FIG. 5 depicts a top view of an exemplary foundation plate of thepresent disclosure.

FIG. 6 depicts a perspective view of an exemplary foundation plate ofthe present disclosure.

FIG. 7 depicts an exemplary foundation plate embedded into thedeformable casting medium formed around the teeth of a model anatomy,together forming an exemplary registration device.

FIG. 8 depicts another top view of an exemplary foundation plate of thepresent disclosure showing the locations of two fiducial markers.

FIG. 9 depicts a CT scan of a subject, showing the location of thefiducial markers of the exemplary foundation plate relative to theanatomy of the subject.

FIG. 10 depicts an exemplary foundation plate adjustor engaged with thefoundation plate of an exemplary registration device positioned aroundthe teeth of a model dentiture.

FIG. 11A depicts a side view of an exemplary foundation plate adjustorengaged with an exemplary foundation plate.

FIG. 11B depicts a front view of an exemplary foundation plate adjustorengaged with an exemplary foundation plate.

FIGS. 12A, 12B, and 12C depict various views of an exemplaryregistration device.

FIG. 13 depicts an exemplary implant plan based on a CT scan of asubject generated using implant software.

FIG. 14A depicts a perspective view of an exemplary sensor array of thepresent disclosure.

FIG. 14B depicts a perspective view of an exemplary sensor array of thepresent disclosure together with a magnetized drill bit.

FIG. 14C depicts a perspective view of an exemplary sensor array of thepresent disclosure mated with the foundation plate of an exemplaryregistration device.

FIG. 15 depicts an exemplary display of a drill bit in operationrelative to a registration device positioned on the anatomy of asubject.

FIGS. 16A, 16B, and 16C depict various views of an exemplary sensorarray separate from and engaged with an exemplary foundation plate.

FIG. 16D depicts a top view of an exemplary sensor array.

FIG. 17 depicts an exemplary sensor array of the present disclosuremated with the foundation plate of an exemplary registration devicepositioned on a representation of the anatomy of a subject.

FIG. 18 depicts a perspective view of an exemplary angle setter of thepresent disclosure.

FIG. 19 depicts an exemplary guide base of the present disclosure.

FIG. 20 depicts an exemplary guide base positioned on an angle setter.

FIG. 21 depicts a top view of an angle setter displaying exemplary tiltand offset angles.

FIG. 22 depicts an angle setter installing a guide collar on a guidebase to create a drill guide.

FIGS. 23A, 23B, and 23C depict a collar pin installing a guide collar ona drill guide base to create a drill guide.

FIGS. 24A, 24B, and 24C depict a drill guide both before and aftermating with a foundation plate and a registration device.

FIG. 25 depicts various drill bit sleeves accepted by the drill guide.

FIG. 26 depicts a drill guide and a sensor array mated with aregistration device positioned on the anatomy of a subject.

FIGS. 27A and 27B depict another embodiment of a sensor array havingadditional (8) paired sensors alone and mated with a foundation plateand registration device, respectively.

DETAILED DESCRIPTION OF THE INVENTION

For clarity of disclosure, and not by way of limitation, the detaileddescription of the invention is divided into the subsections thatfollow.

A. DEFINITIONS

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as is commonly understood by one of ordinary skillin the art to which this invention belongs. All patents, applications,published applications and other publications referred to herein areincorporated by reference in their entirety. If a definition set forthin this section is contrary to or otherwise inconsistent with adefinition set forth in the patents, applications, publishedapplications and other publications that are herein incorporated byreference, the definition set forth in this section prevails over thedefinition that is incorporated herein by reference.

As used herein, “a” or “an” means “at least one” or “one or more.”

As used herein, the term “and/or” may mean “and,” it may mean “or,” itmay mean “exclusive-or,” it may mean “one,” it may mean “some, but notall,” it may mean “neither,” and/or it may mean “both.”

The use of the term “embodiment” means that a particular feature,structure, or characteristic described in connection with the embodimentis included in at least one embodiment of described subject matter. Assuch, the appearance of the phrases “in one embodiment” or “in anembodiment” throughout the present disclosure is not necessarilyreferring to the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments.

As used herein, “treatment” means any manner in which the symptoms of acondition, disorder or disease are ameliorated or otherwise beneficiallyaltered. Treatment also encompasses any pharmaceutical uses of thedevices described herein.

As used herein, “subject” refers to an animal, including, but notlimited to, a primate (e.g., human). The terms “subject” and “patient”are used interchangeably herein.

As used herein, “implant site” refers to an area of the anatomy of asubject designated for introduction of a medical implant such as adental implant, or a site having received a medical implant such as adental implant.

As used herein, “open treatment area” refers to an area of the anatomyof a patient containing and/or adjacent to an implant site. Withreference to a deformable casting medium, an open treatment area refersto an area circumscribed or delineated by the deformable casting mediumas an area open and available for a radiological or surgicalintervention while the deformable casting medium or registration deviceis positioned on the anatomy of a subject. An open treatment area is notencumbered or shrouded by the deformable casting medium. An “opentreatment area” typically refers to the oral cavity or portion of thejaw of a subject, but may also refer to other portions of the body of asubject requiring surgical intervention and/or radiographic analysis.

As used herein, “dental handpiece” or “handpiece” refers to a tool inmedicine, and particularly dentistry, used to drill a hole in the bone,such as a jawbone, of a subject. Drill bits of varying sizes can be usedwith the handpiece and it is often used in conjunction with variousdrill bit sleeves to protect and guide the various drill bits. Thoughdrills and drill bits are discussed extensively herein, the presentdisclosure is equally applicable to additional surgical devices that arecapable of being monitored and/or guided using the devices and methodsused herein, such as needles, catheters, and surgical cutting tools.

As used herein “anatomy” or “anatomical region” refers to a body portionof a subject. Most frequently, the term anatomy refers to a body portionof a subject designated for receipt of an implant, having received animplant, or an adjacent area. “Anatomy” typically refers to the oralcavity or portion of the jaw of a subject, but may also refer to otherportions of the body of a subject requiring surgical intervention and/orradiographic analysis.

As used herein, a “dental implant” or “implant” is a surgical componentthat interfaces with bone, such as the bone of the jaw or skull, tosupport a prosthesis (e.g., dental prosthesis) such as a crown, bridge,denture, facial prosthesis or to act as an orthodontic anchor.

As used herein, “about at” or “at about” refer to an approximation. Withreference to the location of a sensor or device relative to the anatomyor an anatomical portion of a subject, for example, as exemplified inthe Figures. These terms refer most frequently to a vertical distanceindication of the spacing of a device or aspect thereof described hereinsuch as a sensor, fiducial, or physical guide relative to the gumline orjawbone of the subject as below the level of the top of the teeth of thesubject and above or below the gumline or jawbone of the subject. Teethneed not be present for these terms to maintain their directionallyrelative meaning. The term “at or about at” refers to “about at” asdefined above, as well as positioning of the sensor or device relativeto the anatomy or an anatomical portion of a subject “at” a particularlocation, for example adjacent to, and at the same relative verticalorientation as, the level of a gumline or jawbone. Unless specificallydefined otherwise, the terms “top” and “bottom” are directionallyrelative terms as used herein that are intended to refer to a treatmentregion of either the upper or lower jaws of a subject comprising teeth,gumline, and jawbone with the teeth at the top and the jawbone on thebottom. When referring to the “top” of the teeth or a tooth, it isintended to encompass the teeth, or a tooth, of both the upper or lowerjaw and refers to the part of an intact tooth or set of teeth that isfurthest away from the gumline.

As used herein, the terms “upper,” “above,” “lower,” and “below” areused with relative reference to devices, device features, or anatomicalstructures noted herein. For example, an “upper portion” refers to aportion of a device intended to be at or toward the top of the device orcomponent thereof when in use. Conversely, a “lower portion” refers to aportion of a device intended to be at or toward the bottom of the deviceor component thereof when in use. The lower portion of a foundationplate, for example, is most frequently positioned at or below the gumline or jawbone of a subject.

As used herein, “deformable casting medium” refers to a putty, paste,epoxy, or the like comprising an impression material that is deformablein a first state and non-deformable in a second or hardened state. Thereference to a deformable casting medium herein is, unless specificallystated, intended to be open and without reference to whether the mediumis in either a deformable or non-deformable state. In other words, ifthe medium is hardened, substantially hardened, or in a non-deformablestate, it remains to be a deformable casting medium. A variety ofmaterials are contemplated herein as deformable casting mediums,including materials comprised of vinyl poly siloxane, poly ether,polysulfide, alginate, and zinc oxide eugenol paste, among othermaterials. One example of a commercially available deformable castingmedium of the present disclosure comprises impression materials such asProvil® Novo (Heraeus Kulzer, LLC; South Bend, Ind.). Other examplesinclude Exafast (GC America; Alsip, Ill.), Express (3M; St. Paul,Minn.), Genie (Sultan Healthcare; York, Pa.), Impregum (3M; St. Paul,Minn.), Imprint (3M; St. Paul, Minn.), and Position Penta (3M; St. Paul,Minn.).

As used herein, and unless specifically indicated, “dentist” is intendedto generally refer to a medical professional in the dental or medicalfields, including an assistant to a dentist, doctor, radiologist, orsurgeon. As such, those qualified or able to undertake any or all of theprocedures set forth herein are intended to be encompassed by the term“dentist.”

As used herein, “radiological scan,” “radiological imaging,” or“radiographic analysis” refers to diagnostic images of anatomicstructures through the use of electromagnetic radiation or sound waves.Radiological imaging techniques contemplated herein include, forexample, x-rays, computed tomography or computerized axial tomography(CT) scans, positron emission tomography (PET) scans, magnetic resonanceimaging and spectroscopy (MRI), and ultrasonograms.

As used herein, “disposable” refers to a device or apparatus intended tobe utilized in a single procedure (radiographic, surgical, or both) orwith a single subject and then discarded. Often, “disposable” refers toinstructions for use or operation of the apparatus or device as intendedfor disposal after a single procedure or with a single subject. Themeaning of “disposable,” as used herein, excludes items that areintended to be used with multiple subjects (e.g., items intended to becleansed/sanitized/autoclaved and re-used on multiple subjects) as wellas nonsensical single use applications (e.g., disposing a dentalhandpiece or CT Scanner after a single use or use with a singlesubject). Each of the innovative guide devices and apparatuses describedherein may be disposable unless specifically indicated.

As used herein, the term “removable” or “removably” refers to acharacteristic of a device or apparatus contemplated herein as, orpermitting it to be, physically positioned in one location relative tothe anatomy of a subject or another device or apparatus and then takenaway from that position. This is contrary to permanent placement viascrews, staples, stitches, bolts, adhesive or the like. For example,“removable” or “removably” excludes attachment of a device and/or itsassociated components to the anatomy of a subject via surgicalintervention such as through the use of a screw inserted into a tissueof the subject.

As used herein, “fiducial” refers to a fiducial marker or object thatwhen placed in the field of view of an imaging system, such as aradiographic scan, appears in the image produced.

As used herein, “surgical intervention” refers to a physicalintervention on one or more tissues of a subject.

Subject evaluation for implantation purposes is a process where asubject is assessed to determine whether they are a candidate for animplant. A variety of factors are taken into account in this process,including the status of the site of the implant, including thepositioning and morphology of anatomical landmarks at and near the site.Subject evaluation often mandates a 3-dimensional radiographic scan suchas a CT scan, which provides a 3-dimensional view of the subjectanatomical structures. In some embodiments, the 3-D radiographic scanprovides a 3-dimensional computer representation of the dentition,maxilla and/or mandible and associated dental structures of the subject(i.e., the anatomy of the subject) by virtue of cross-sectional imagesas known in the art. In some embodiments, the 3-dimensional radiographicscan provides a controllable 3-dimensional image using computer graphicmethods well-known in the art. The 3-dimensional radiographic scan isstored in the system for later operation.

The present disclosure is intended to enhance and ease the patientevaluation process, increase the amount of useable information obtainedfrom scans such as CT scans, and to increase accuracy and minimize risksof undertaking surgical interventions such as implant procedures.

According to the present disclosure, and with reference to the devicesand systems described herein, a typical subject would be exposed toand/or benefit from at least some of the following processes andprocedures. A subject at some point in the process presents to a dentistwith a surgical intervention site such as an implant site.

Foundation Plate and Registration Device

With reference to FIGS. 1 and 2, the dentist or dental assistantmeasures out and mixes a deformable casting medium such as impressionputty 11. The dentist then places the fully mixed putty 11 into theinner portion 14 of a molding tray 10. In an exemplary molding tray 10,a treatment area void 12, optionally defined by walls 13, is included.The treatment area void 12 defines a treatment area devoid of thedeformable casting medium 11. In frequent embodiments, the treatmentarea void 12 is dimensioned to match the implant site 16, betweenexisting teeth in the subject. This dimensioning eases the shaping ofthe deformable casting medium 11 to match the implant site andsurrounding regions of the subject's anatomy 15, 17 to facilitate latersteps of the procedure. The resulting effect of this can be seen, forexample, in FIG. 4 where the deformable casting medium 11 surrounds theimplant site 16. As can be seen in FIGS. 3 and 4, the dentist theremoves the deformable casting medium 11 and places it over the implantsite 16, forming it to the teeth 17. Though molding tray is often notnecessary to the present methods, it eases the accurate placement of thedeformable casting medium on the anatomy of the subject.

With reference to FIGS. 5-8, the dentist utilizes a tool such as rubberdam clamp forceps to manipulate the prongs 24 of a foundation plate 20(also referred to herein as a “radiographic guide”) into the deformablecasting medium 11 in a desired orientation circumscribing the implantsite 16. Often the foundation plate 20 is provided with directionalindicia 23 to facilitate proper placement of the foundation plate 20. Inthe depicted example, directional indicia 23 (e.g., arrows) face theoutside of the mouth of the subject.

An exemplary foundation plate 20 has a variety of features, exemplifiedin the Figures and briefly described as follows. In the depictedexample, the foundation plate 20 is an open arched contiguous loop ofmaterial, which can be the same or different materials and may comprisean assembly of materials having the same or different physicalcharacteristics. The material of the foundation plate 20 can be any of avariety of types of plastics and/or metals and can be molded, assembled,milled, or 3-D printed. Geometrically, the exemplary foundation plate 20is defined by upper portions 27, each having bilateral sloping arms 35,having attachment points 21, 29 for a secondary device such as a sensorarray 40 (FIGS. 14, 16-17, 26). The bilateral sloping arms 35 may be thesame or different material and shape as the upper portions 27, and theirdelineation is generally indicated by a bend or different angulationversus a respective upper portion 27. In certain limited embodiments theupper portion 27 is comprised as a bend extending between, simply anintersection between, or the top/ends of, two separate bilateral slopingarms 35. The attachment points can be of the same or different size,shape, or orientation. In the exemplary foundation plate 20, attachmentpoints 21 are comprised of holes in the material that are larger thanthe holes comprising attachment points 29. Providing different size,shape, or orientations for the attachments points has been found to beuseful to ensure proper orientation of the sensor array 20. Moreover, ifthe exemplary sensor array 40 is intended to become a permanent fixtureon the foundation plate 20 once it is attached, providing size, shape,or orientations of the attachment points 21, 29 facilitates removal andproper placement of the sensor array 40 if initially installed in anincorrect orientation on the foundation plate 20.

In certain embodiments, the particular geometric arrangement ofsupportive features of the foundation plate is not important to achievethe overall purpose of providing a base for situating a sensor arrayand/or physical guide, while not vertically or laterally inhibiting orobstructing a treatment area. In this regard, the foundation plate maybe comprised of multiple units assembled together. So, although apreferred embodiment involves bilateral sloping arms, such anarrangement is not required. One objective of the foundation plate is topermit accurate, and optionally removable, placement of sensors or aphysical drill guide relative to a surgical site such as an implant siteor open treatment area. This placement is most frequently at the levelof a tissue of the patient (e.g., gum line or jawbone) where a drill oranother surgical device will penetrate the tissue. This level isfrequently immediately adjacent of the tissue. Often, in a dentalimplant embodiment this placement is between the level of the top of theteeth of the subject and the gum line or jawbone. As such, regardless ofthe physical configuration, a foundation plate of the present disclosureaddresses these and other objectives pertinent to placement of guidesand sensors as close as possible to the level of tissue where thesurgical intervention is to occur, and other objectives.

Lower portions 36 connect each of the arms 35 of the foundation plate 20and can be the same size, shape, orientation or can differ in one ormore of these aspects. Often, when one of the lower portions 36 differsfrom another lower portion in the same foundation plate it is for thepurpose of directional orientation of a separate device such as a sensorarray 40, foundation plate adjuster 30, or guide base 80. The lowerportions 36 are often defined by one or more of the following features.Most frequently the lower portions 36 include laterally extending feet(also referred to as prongs) 24 for insertion into a deformable castingmedium 11. Four prongs 24 are depicted, but fewer or additional prongscould be included, and their size and shape could be altered as long asthey serve the function of supporting the foundation plate 20 within thedeformable casting medium 11.

The lower portions 36 also frequently include fiducial marker areas 28containing or comprising fiducial markers 26, which in the depictedexample provide them in the shape of a square. Other simple geometricorientations of the fiducial markers 28 are contemplated, such astriangle or rectangle, though square orientation is most frequentlypreferred. The fiducial markers 26 can be embedded, encased, or attachedto the lower portions 36 and are limited to materials that show up, orare noticeably absent, when subjected to radiographic imaging such as byway of an X-ray, CT scan, or MRI. See FIG. 9. The fiducial markersgenerally create size and position context relative to a subject'sanatomy, and assures precise correlation between anatomy and aradiographic scan such as a CT scan. Fiducial markers 26 of the presentdisclosure are generally recognized by implant software contemplatedherein. Metal balls are one example of a fiducial marker 26 contemplatedherein. Also optionally present on the lower portions 36 are forcepsnotches 22 to permit simplified gripping and placement into a deformablecasting medium 11 using rubber dam clamp forceps. Interface aspects foruse in conjunction with similar devices are also contemplated. Moreover,the lower portions 36 also most frequently include features 25 servingas attachment points for a separate device such as a foundation plateadjuster 30 or guide base 80.

The foundation plate 20 is frequently provided in an orientation and iscomprised of materials that provide resiliency to permit the lowerportions 36 to be spread away from one another and, without additionalinput, they spring back to their original or approximately originalshape or orientation. In certain embodiments, the foundation plate isprovided with an actuating mechanism (not depicted) that permits it tobe oriented in a first open position and upon activating the actuatingmechanism, the lower portions are induced to move to a second closedposition. Without regard to whether a mechanism is present or not, anopen position refers to a position permitting the foundation plate 20 tobe placed around a deformable casting medium 11 or an open treatmentarea, and a closed position refers to a position where the prongs 24 aregripping, or positioned to grip, a deformable casting medium 11 or theanatomy of a subject.

The foundation plate exemplified herein is not intended to be limited toany particular materials or physical arrangement with the limitationthat it provides reliable placement of a fiducial, a sensor, and or aphysical guide at about the anatomy or implant site of a subject (suchas a gumline) intended for radiographic investigation or surgicalintervention.

Referring to FIG. 7, when placing an exemplary foundation plate 20, itis gripped by an attachment apparatus such as forceps and the lowerportions 36 are spread laterally or tensioned away from one-another. Thefoundation plate 20 gripped by the attachment apparatus is then loweredover a deformable casting medium 11 previously applied to the oralfeatures 15, 17 of the subject surrounding an implant site 16 or theanatomy of the subject. When positioned at an approximately correctlocation circumscribing an implant site 16, the tension is releasedbetween the bilateral sloping arms 35 and the prongs 24 are permitted tocontact and embed within the deformable casting medium 11. This processis generally undertaken in short order after the deformable castingmedium 11 is placed in the subject so that the casting medium is stillin a malleable state, permitting easy placement and embedding of theprongs into the medium. These deformable mediums are well known in theart and have known timing and parameters for hardening.

In certain embodiments, the foundation plate is positioned around oradjacent to an open treatment area, implant site, or anatomy of asubject without the use of a deformable casting medium.

With reference to FIGS. 10 and 11A-B, once the foundation plate 20 ispositioned circumscribing an implant site and at least partiallyembedded in the deformable casting medium 11, it may be optionallyadjusted using a foundation plate adjuster 30, which is attachable to orsurrounding lips 25 of the foundation plate 20 using exemplary features33. As depicted in FIGS. 11A and 11B, the dentist uses the foundationplate adjuster to check the spread, depth, and/or anglulation of thefoundation plate. The handle 30 can be used to manipulate base 32 andlips 33 and, as a result, the foundation plate 20 is manipulated. FIG.11A provides a side view, indicating that manipulation can be side toside or vertically. FIG. 11B provides a front view, also indicating thatmanipulation can be side to side (i.e., a first and second lateraldirection) or vertically. It will be understood by one of skill in theart that movement side-to-side here may frequently involve movement inan arc from side-to-side. Typically, the lower portions 36 are pusheddown to the gumline and one or more of spread and angle of thefoundation plate 20 on the subject are manipulated and set.

With reference to FIGS. 12A-12C, once the proper spread, depth, andangle has been set, the dentist will let the deformable casting medium11 cure or harden around the various anatomical features of the subject.Once cured, the foundation plate 20 will be set in the hardeneddeformable casting medium 11, creating a registration device 50comprised of the deformable casting medium 11 and the foundation plate20. The registration device 50 can then be removed from the mouth of thesubject and reliably replaced in its original location for radiographicinvestigation or surgical intervention. In certain embodiments, theregistration device 50 is removed and brought with the subject to obtaina radiographic (e.g., CT) scan at a location remote from the locationwhere it was made. For example, the subject may have to go to adifferent room or location, immediately thereafter or at a later time orday, to obtain a radiographic scan.

At the time of the radiographic scan, the subject, doctor or dentistplaces the registration device 50 on their anatomy prior to the scan. Asdepicted in FIG. 13 (and FIG. 9), the fiducials in the foundation plate50 show up in the CT scan and allow the implant software to record orevaluate the size and position of the registration device. The CT scanestablishes, for example, maximum depth, probable maximum implantdiameter, precise angle for tilt (front to back) for the implant, andangle offset (side to side) for the implant. With the CT scan results,the dentist then creates an implant plan using any of a variety ofcommercially available implant software programs. An algorithm is usedbased on the locations and positions of the fiducials identified in theradiographic scan that defines a plane relative to the anatomy of thesubject, and calculates tilt, offset, and depth for the implant. Often,a guide path for the drill bit is defined by the implant software. Thedetermination of the positions of the fiducials may include the stepsidentifying each fiducial and a relationship of each relative to eachother and/or the anatomy of the subject. In certain embodiments, therelative size or intensity of each fiducial in the radiographic scanprovides an indication of location and/or to depth of each fiducial.

In certain embodiments, the registration device 50 is used to generateradiographic scans of the implant site and is not used during theimplantation procedure. In certain other embodiments, the registrationdevice 50 is used to generate radiographic scans of the implant site andis used during the implantation procedure alone, or together with asensor array 40, a physical drill guide 96, or a hybrid physical andsensor drill guide 97.

Sensor Array

With reference to FIGS. 14-17, the dentist is provided the registrationdevice 50 and refers to implant software. The dentist then opens a freshsensor array 40 package and activates it, for example, by depressing thesensor activation button 52 on the transponder 41. The computer systemcontaining the implant software then wirelessly acknowledges the newsensor and inquiries if it has acknowledged the correct sensor forconnection. Frequently, each sensor will have a unique identifier,electronic or otherwise, that is transmitted and picked up by thecomputer system and implant software to ensure that the correct sensoris utilized in the procedures that follow. The dentist is frequentlyprovided an opportunity on the software to accept or reject theparticular sensor identified by the software. In frequent embodiments,the dentist verifies the operability of the sensor array 40 by passing,for example, a standard such as a magnetized drill bit 55 or anotherdevice or standard through the center area 100 of the sensor array 40,simulating at least an approximation of the intended drilling path.Often, the monitor of the computer system containing the implantsoftware will display a representation of the standard (e.g., virtualdrill bit 55) as it passes through center area 100, if working properly.This process often occurs prior to attaching the sensor array 40 to theregistration device 50, but may occur after attachment as well.

Upon confirmation of the working sensor array 40, the dentist thenattaches the sensor array 40 to the registration device 50. The dentistthen places the combined device onto the anatomy of the subject andbegins the implant procedure, using visual feedback on the computermonitor. In related embodiments, the registration device may be placedon the anatomy of the subject prior to attachment of the sensor array40.

In frequent embodiments, directional indicia 46 showing proper placementof the sensor array are provided. In the depicted example, thedirectional indicia 46 are arrows that point out toward the cheek of asubject when properly oriented and in the mouth of a subject. Thedentist attaches the sensor array 40 to the registration device 50 uponaligning the directional indicia 46 of the sensor array 40 with thedirectional indicia 23 of the foundation plate 20. The sensor array 40optionally includes pegs 44, 49 of multiple sizes that match with thesize of the attachment points 21, 29 of a foundation plate when orientedin the proper direction. In certain frequent embodiments, theregistration device 50 and sensor array 40 are devices that are intendedto be disposable and useable with a single patient. In thesecircumstances, the mating of the sensory array 40 with the registrationdevice 50 is intended to be a permanent mating or a mating that requiressignificant effort to remove the sensory array 40 after attachment. Theuse of different sized pegs 44, 49 and attachment points 21, 29 isuseful in these embodiments as it ensures that the sensor array 40cannot be mated with the registration device improperly. In a typicalembodiment, the sensor array 40 slides over top of the foundation plate20 and the sensor pegs 44, 49 engage attachment points 21, 29 in thefoundation plate 20.

Similar to the foundation plate 20, the sensor array 40 is frequentlycomprised of an open arch of material, which can be the same ordifferent materials and could comprise an assembly of materials havingthe same or different physical characteristics. The material of thesensor array 40 can be any of a variety of types of plastics and/ormetals and can be molded, assembled, milled, or 3-D printed.Geometrically, the exemplary sensor array 40 is designed to mate withthe geometry of the foundation plate 20. Frequently, the sensor array 40is defined by upper portions, each having bilateral sloping arms, havingpegs 44, 49 for attachment to a foundation plate 20 (FIGS. 14C, 16-17,26). The bilateral sloping arms may be the same or different materialand shape as the upper portions, and their delineation in exemplaryembodiments is generally indicated by a bend or different angulationversus a respective upper portion. In certain limited embodiments theupper portion is comprised as a bend extending between, simply anintersection between, or the top/ends of, two separate bilateral slopingarms. The pegs can be of the same or different size, shape, ororientation; or another physically integrating aspect or mechanism isuseable in replacement or together with the exemplified pegs, with therequirement that the sensor array 40, or portion thereof, mate with thefoundation plate 20 or registration device in a pre-determined manner ororientation.

Lower portions 43, 45 connect at least two of the arms of the sensorarray 40 and can be the same size, shape, orientation or can differ inone or more of these aspects. Most frequently, lower portions 45 arecomprised of two physically separated or unconnected portions. Thoughlower portions 45 are connected with the arms of the sensor array 40,their separation defines a gap that is vertically and/or laterallyunimpeded to center area 100. Importantly, the sensor array mostfrequently includes a gap that is vertically and/or laterally unimpededto center area 100. This gap will generally face toward the outside ofthe mouth of the subject, i.e., the area from which the dentistapproaches the implant site 16. This gap provides both physical andvisibility access to center area 100, which when the device is placed onthe anatomy of the subject, defines at least a portion and preferablyall of the implant site 16. Therefore, in the most frequent embodiments,the use of the sensor array does not alter the physical or visibilityaccess to, or methods of accessing, the implant site 16.

In a frequent embodiment, as depicted in FIG. 14, four electromagneticsensors in a perfect square are embedded in the lower portions 43, 45 ofthe sensor array 40. In another frequent embodiment, as depicted inFIGS. 27A and 27B, eight electromagnetic sensors are provided embeddedin the lower portions 43, 45 of the sensor array 40 with a paired sensorsituated above the sensor embedded in the sensor array. Whether thesensor is embedded in the material of the sensor array is ofteninconsequential to the operation of the sensor array. Thoughelectromagnetic sensors are exemplified, other conventional mechanismsof sensing the placement, angulation, and/or orientation of a surgicaltool such as a drill bit are contemplated in certain limitedembodiments. For example, U.S. Pat. Nos. 6,665,948, 7,457,443,8,224,025, and 8,734,153, and U.S. Patent Application Pub. Nos.20050116673 and 20120237892, each of which is incorporated herein byreference.

In use, the location and angular orientation of the drill bit of thedental handpiece relative to the sensors is determined and related datais sent to a computer system for display alone, or more frequentlyoverlaid on a CT image of the anatomy of a subject. Frequently, an imageof the patient's dentition and a depiction of the location and angularorientation of the drill bit is displayed. See, e.g., FIG. 13, 15. Theimage can be provided in a variety of levels of granularity, including adepiction of the drill bit itself, or representations of the drill bitin the form of vectors, lines, colorings, or other indicators. Cues inthe form of physical feedback such as a vibration are also contemplated.In certain embodiments, the positioning and orientation of the drill bitmay be indicated through generic indicators such as a typed or spokenword, a noise, or a color. These indicators are based on the location,tilt, offset, and depth of the drill bit are calculated by the systemusing an algorithm relative to the representation of the anatomy of thesubject generated using the radiographic scan and may optionally beprovided to the dentist using above-noted or other similar non-visualcues, or in replacement of visual representation thereof. Often, visualrepresentations are provided on a display, optionally with real timedata or images overlaid on a static or real-time image of the anatomy ofa subject. Multiples of any one of these or combinations of any two ofmore of these types of indicators are contemplated embodiments. In oneembodiment, the system provides only an auditory accounting of the tilt,offset, and/or depth during the procedure. In one embodiment, the systemprovides only a physical feedback (e.g., vibratory) accounting of thetilt, offset, and/or depth during the procedure. In another embodiment,the system provides both a visual and an auditory accounting of thetilt, offset, and/or depth during the procedure. In other embodiments,the system provides only a visual accounting of the tilt, offset, and/ordepth during the procedure. In another embodiment, the system providesboth an auditory and physical feedback accounting of the tilt, offset,and/or depth during the procedure. In another embodiment, the systemprovides both a visual and physical feedback accounting of the tilt,offset, and/or depth during the procedure. In another embodiment, thesystem provides a visual, auditory, and physical feedback accounting ofthe tilt, offset, and/or depth during the procedure. The presentdisclosure includes receiving real-time data from the sensor system, anddetermining from the updated data an updated location and angularorientation of the drill bit in relation to the anatomy of the subject.The image on the display and/or auditory signal is updated and adjustedto provide the updated location, tilt, and offset orientation of thedrill bit in relation to the anatomy of the subject. In this way, realtime feedback is shown, indicating how the drill bit correlates to theanatomy of the subject.

The placement of the electromagnetic sensors in the lower portions 43,45 of the sensor array 40 is a significant development and innovation.Placement in the lower portions 43, 45 places the sensors close to or atthe surface of the bone of the jaw of the subject at or near the implantsite 16. As can be seen in FIG. 17, for example, the lower portions 43,45 are below the top of the teeth 17 and at, near, or approaching thebone of the jaw 15. In other words, the electromagnetic sensors of thesensor array 40 are oriented vertically at or approaching the top of thebone of the jaw 15, thus providing sensor coverage very close to theentry point of a drill into soft tissue and bone of the jaw 15. Theinventors have determined that placement of the sensors close to thebone of the jaw 15 of a subject is beneficial versus the prior proposedmethods and apparatus. For example, the distance that the drill bit musttravel prior to contacting the anatomy of the subject after passingthrough the sensors is minimized for better accuracy of depth, tilt, andoffset, determinations for the bore hole. Moreover, the distance thatthe drill bit has to travel after exiting a drill bit sleeve (if used)is minimized, thus providing better stability to the drill bit andenhanced safety for the subject.

Exemplary sensors are located near the gum line, instead of beingclustered close together around the drill hole at a high level wellabove the tooth surfaces. In frequent sensor arrays 40, exemplaryelectromagnetic sensors are also spatially spread out beyond theboundaries of teeth 17 and gums of the subject, but at or adjacent tothe gum line 15 and away from the implant site 16. The implant site 16is therefore more accessible and unencumbered, with excellent access andvisibility and far greater accuracy. These sensors pick up the movementof a drill bit very close to the implant site to ensure properdirectional accuracy and depth monitoring and calculations. The sensorscan provide a real-time representation of the position of the drill bitrelative to the implant site. Often, a drill position indicator isoverlaid and co-displayed with one or more images from the radiographicscan.

The sensor array exemplified herein is not intended to be limited to anyparticular materials or physical arrangement with the limitation that itprovides reliable placement of a sensor at about the anatomy or implantsite of a subject (such as a gumline) intended for radiographicinvestigation or surgical intervention.

Importantly, a conventional dental drill handpiece can be utilized inconjunction with the present devices, systems, and kits. This drillhandpiece need not be modified and add-on devices or sensors for thehandpiece are unnecessary according to the present disclosure.

As also indicated, the sensor array 40 also includes a data transponder41 such as a blue tooth transponder 41. Though a Bluetooth transponderis preferred, any known mode of data transfer could work in the presentsystems and methods that have the capability of transmitting data aboutthe spatial orientation or other information about a surgical instrumentdetected by the sensors of the sensor array 40. Other exemplary datatransfer modes include touch memory, radio-frequency identification(RFID), wired connection, or other modes. The data transponder 41 isgenerally dimensioned physically such that it will fit between the gumand cheek of a subject throughout an implant procedure. In frequentembodiments, the transponder is provided with a portable and limitedtime duration power source, such as a battery. Often the battery poweris capable of providing power to the transponder for a limited time.This “limited time” is often about 30 minutes or less. Most frequently,the limited time is less than two hours, less than an hour, or less than45 minutes. As many of the devices of the present disclosure areintended to be disposable to ensure that they cannot be re-used onmultiple patients to reduce cross-contamination and to enhance accuracy,a power source having a limited time duration is a frequent option. Forexample, once the transponder 41 is activated, the power source iscapable of transmitting data for a limited time as noted above. Thetransponder provides registration of the sensor array with the computersystem to provide real-time indication or visualization of the drillbit. The transponder may be permanently attached or releasably connectedwith the sensor array. In certain embodiments, the transponder isreleasably attachable to one or more sensor array.

In some embodiments, a software application of the sensor systemcombines the location and orientation data for the drill bit, fiducialreferences, designed implant location, depth, tilt, and offset, andprovides real-time information to the dentist of the drill bit progressrelative to the anatomy of the subject. Often, the software algorithmcalculates the location and/or orientation of the drill bit relative tothe desired implant shaft, the planned depth of the implant bore orother anatomical structures near or adjacent to the bore. Also often,the system provides a warning message or indication to the dentist ifthe drill bit tilt, offset, or depth deviates beyond a pre-set thresholdfrom the desired parameters. The warning message or indication, as notedherein, is provided in a visual, auditory, and/or physical feedbackmanner. Prior to drilling into available bone, the dentist mayoptionally move gingival tissue via conventional methods by, forexample, incising to form a flap.

In frequent embodiments, the registration device 50 is used togetherwith the sensor array 40 during an implantation procedure. Often, theregistration device 50 is used together with the sensor array 40 duringan implantation procedure without the use of a physical drill guide 96.

Physical Drill Guide

The present disclosure also contemplates the use of a drill guide thatprovides physical orientation of a drill bit in a surgical procedure.The description below outlines some characteristic features of themethods and apparatus utilized in these embodiments.

With reference to FIGS. 18-23, an angle setter 60 apparatus is describedthat facilitates the fabrication of a physical guide that can be usedtogether with the foundation plate 20 or registration device 50. In themost frequent embodiments, the angle setting apparatus is notdisposable, as that term is used herein. The purpose of the fabricationis to create a device (together 80 & 90) that ensures the tilt andoffset angles determined in a radiographic scan (e.g., CT scan), asexplained above, as the optimal drill angles for an implant procedurefor a specific subject can be replicated during a surgical procedure onthat subject.

FIG. 18 depicts an exemplary angle setter 60 of the present disclosure.This angle includes some or all of the following features. A hole 62 isfor a collar pin 91 and an actuating mechanism such as a knob 63 forlocking the angle arm head 61 in place in a predetermined orientation onthe angle arm 65. The angle arm head 61 can often move in an arc acrossthe angle arm 65, most frequently up to 90 degrees of angular travel,but most frequently within 45 degrees of vertical, or within 30 degreesof vertical. The angle arm often includes analog/physical angularsettings 64 to show the placement of the angle arm head 61 on the anglearm 65. A swivel base 66 is included that can rotate in one or twodirections up to about 360 degrees of rotation, or is capable ofrotating freely in the angle setter base 72. An actuating mechanism suchas a knob 73 is included to lock the swivel base in place in apredetermined orientation. The swivel base 66 often includesanalog/physical angular settings 67 to show the placement of the swivelbase 66 within the base 72 and with respect to the location of the anglearm 65 or a centering mark 74. The swivel base 66 includes a feature 68to support a guide base 80 and directional indicia 69 to ensure properplacement of the guide base 80 on the swivel base 66 to provide accurateangular placement of the guide collar 90. An optional digital display 70is electronically coupled to the angle arm head 61 and the swivel base66 and shows the angular readout of the angle arm head (angle A) andswivel base (angle B). The angle arm head 61 rotates for proper angularadjustment of angle A. The swivel base 66 rotates for proper angularadjustment of angle B. The power button 71 turns the digital readout 70on and off. Rotation of the swivel base 66 and travel of the angle armhead 61 can be manual or automated.

When using an exemplary angle setter 60 having a digital display, thedentist begins by initiating the digital readout 70 of the angle setter60. The calibration of the angle setter 60 is verified, for example, bycomparing the analog/physical settings 64, 67 on the swivel base 66 andangle arm 65 with those displayed on the digital readout 70, 75. Withreference to FIGS. 19-20. The dentist removes a fresh guide base 80 fromits packaging and places it into the angle setter 60. The guide base 80often includes directional indicia 84 and the guide base 80 is placed infeature 68 on the swivel base 66 in an orientation that aligns with thedirectional indicia 69 of the swivel base 66. The guide base 80 alsofrequently includes a physical feature or features such as lips 82, 83,each having different dimensions, to ensure proper placement of theguide base on swivel base 66 and foundation plate 20. Most frequently,the guide base 80 includes a base opening 81 having surroundingchamfered edges for positioning of a guide collar 90. Features 85, 86also can be provided to physically cooperate with features 25 of thefoundation plate 20 to attachment thereto.

With reference to FIGS. 21-23, the dentist then adjusts the angle setter60 to the angles generated by the implant software, for example,starting with angle “A” and locking it in place with actuating mechanism63. Optionally, the software is connected with the angle setter 60 suchthat the adjustments necessary for the angle adjuster are setautomatically by the software or an interface between the software andthe angle setter 60. Angle “B” is also adjusted and locked it into placewith actuating mechanism 73. With angles A and B set, the angulation forthe collar pin 91 to adjust the guide collar 90 is set. The dentist thenchooses a specified size guide collar 90, which acts in frequentembodiments as a drill depth control. The guide collar 90 size canoptionally be provided or suggested by the implant software based on thephysical features of the anatomy of the subject as they were determinedfrom the radiographic scan. A variety of sizes are contemplated,including heights such as 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7mm, 8 mm, 9 mm, 10 mm or larger, including intervals therebetween. Theguide collar 90 contains a central opening 95 that is designed toaccommodate one or more drill bit sizes or one or more drill bit sleevesizes. This central opening 95 is most frequently operable to be atleast partially coaxially situated or co-extensive with the base opening81. For example, when the guide collar 90 is affixed to the guide base80, an opening extends through the central opening 95 from the top ofthe guide collar 90 to the bottom of the guide collar 90 and out throughthe base opening 81.

A collar pin 91 is then passed through hole 62 (FIG. 18) and a tip 92 ofthe collar pin 91 is inserted into the central opening 95 of the top ofa guide collar 90 to align the guide collar with the angulation of thecollar pin 91 as it sits in an indentation 84 of the guide base 80. Thecollar pin 91 applies a force 93 to capture the guide collar 90 againstthe guide base 80. The dentist then applies an adhesive to the drillguide collar 90 and/or guide base 80 (area noted as aspect 94), toadhere them together and setting the tilt and offset of the guide collar90. The adhesive may be of the type that is cured using UV light, suchas a light-activated resin. Similar dental adhesives and cements, lightcured and non-light cured, are known in the art and are alsocontemplated in the embodiments described herein. Though adhesive isexemplified, other methods of permanent or semi-permanent attachment ofthe guide collar 90 to the guide base 80 are contemplated, includingsnap-fit attachments and co-molding. In certain limited embodiments, theguide base 80 and guide collar 90, individually or together includingthe requisite tilt and offset angulations, are fabricated by a 3-Dprinter.

Once the physical drill guide 96 (also referred to herein as a “physicalguide”) is fully cured, it can be removed from the angle setter 60 andclipped in place on the registration device 50. FIGS. 24A-24C. Thedevice is then placed onto the anatomy of the subject. The dentist canthen begin the implant procedure, using interchangeable drill bitsleeves FIG. 25, 110 according to the size of drill bit being used.

In certain embodiments, the physical drill guide is used without thesensor array. In such embodiments, real-time data regarding theorientation and depth are not provided on a computer system. Rather, thephysical drill guide 96 is operable according to the methods describedherein using apparatuses having the functionalities described herein toprovide the requisite orientation and depth stop for the drill bit. Theorientation and drill bit depth stop are determined, for example, usingradiographic scan information using the registration device 50. Thechoice of size of the guide collar 90 provides the drill-bit depth stopand the orientation of the guide collar 90 on the guide base 80 isoperable, for example, to match information obtained from theradiographic scan and implant software, if utilized.

The physical guide exemplified herein is not intended to be limited toany particular materials or physical arrangement with the limitationthat it provides reliable placement of a physical guide for a drill-bitthat is custom set to the specific orientation and depth required tocarry out a surgical intervention and is placed at about the anatomy orimplant site of a subject (such as a gumline) intended for radiographicinvestigation or surgical intervention.

Hybrid Physical and Sensor Guides

In addition to the sensor and physical guide embodiments of the drillguide described herein, another collection of embodiments iscontemplated and described that involves the combination of some or eachof the features of the sensor and physical guide embodiments into ahybrid physical and sensor drill guide 97. An exemplary embodiment isdepicted in FIG. 26—each of the features of these embodiments isdescribed elsewhere herein. In its use, upon confirmation of the workingsensor array, the dentist then clips the sensor array 40 onto thefoundation plate 20 of the registration device 50. The physical drillguide 96 is often attached to the foundation plate 20 of theregistration device 50 prior to attachment of the sensor array 40.Similar to the physical drill guide and sensor only drill guides above,together the registration device 50, physical drill guide 80, 90 and thesensor array 40 form a unit when attached that is intended to bedisposed after use in designing and carrying out an implant procedure.

In use the hybrid device is placed onto the anatomy of the subject andthe dentist can then begin an implant procedure using interchangeabledrill bit sleeves 110 with the Physical Guide, according to the size ofdrill bit being used. Sensor feedback will also be shown on the systemscreen on the implant software. This arrangement pre-determines and setsa proper drill path without a dentist having to guess where to go orstruggle with visibility and a cumbersome high level drill guide.Significantly, using the hybrid or sensor guides described hereinprovides visual confirmation of the correct drill pathway in real timeon the computer monitor. Unlike trying to achieve this benefit by usinga currently available computer generated drill guide with a pre-set holerequiring a pathway that starts well above the tooth surface level andrequires extra-long drill bits, the present systems provide the dentist,not the lab, full control over the entire pre-set or fabricationprocess. The dentist can now see everything clearly through the use ofthe hybrid guide, which combines an accurate mechanical pre-set pathwayand visual confirmation that the drill bit is entering and passingthrough bone exactly where it belongs. Moreover, in each of theembodiments described herein the dentist has an open and accessible workarea defining the implant site that can be viewed directly during animplant procedure while the physical guide, sensor, or hybrid drillguide embodiments are being utilized with a subject.

Other features and advantages of the invention will be apparent from thefollowing detailed description, and from the claims.

The present invention is described or illustrated using a variety ofexamples provided herein. The examples are provided solely to illustratethe invention by reference to specific embodiments. Theseexemplifications, while illustrating certain specific aspects of theinvention, do not portray the limitations or circumscribe the scope ofthe disclosed invention.

Moreover, while dental implantation provides the majority of theembodiments described herein, the disclosure is not intended to belimited to such embodiments. Rather, without departing from the overallthrust of the present disclosure, the teachings may be readily appliedto surgical interventions or radiographic analyses involving additionalportions of a subject's anatomy.

Citation of the above publications or documents is not intended as anadmission that any of the foregoing is pertinent prior art, nor does itconstitute any admission as to the contents or date of thesepublications or documents.

We claim:
 1. A surgical guide device comprising one or moreelectromagnetic sensors, wherein the surgical guide is operable toposition the one or more sensors at about the gumline of a subject whenthe surgical guide is removably positioned at an implant site on thesubject.
 2. The surgical guide device of claim 1, comprising: a sensorarray having an open arched material defined by a first and second upperportion perpendicularly situated to a lower portion, each upper portionhaving a pair of bilateral sloping arms, wherein the lower portion isconnected to a bilateral sloping arm of each of upper portions; a sensorcomprised in the lower portion; and a transponder in communication withthe sensor and configured to transmit data received by the sensor to aremote processor.
 3. The surgical guide device of claim 2, wherein thetransponder is powered with a low power battery.
 4. The surgical guidedevice of claim 1, wherein the one or more sensors comprise pairedsensors.
 5. A surgical guide device comprising a physical guide, whereinthe surgical guide is operable to position the physical guide at aboutthe gumline of a subject when the surgical guide is removably positionedat an implant site on the subject.
 6. The surgical guide device of claim5, wherein the physical guide comprises a guide base having a guidecollar affixed to the guide base, wherein an orientation of the guidecollar on the guide base is provided by an angle setting apparatus.
 7. Aradiographic guide device comprising one or more fiducials, wherein theradiographic guide is operable to position the fiducials at about thegumline of a subject when the radiographic guide is removably positionedat an implant site on the subject.
 8. The radiographic guide device ofclaim 7, further comprising: a deformable casting medium defining anopen treatment area; and wherein the radiographic guide and thedeformable medium are comprised of different materials, and thefoundation plate is positioned in contact with the deformable medium. 9.The radiographic guide device of claim 7, wherein the radiographic guidecomprises an open arched material defined by a first and second upperportion perpendicularly situated to a first and second lower portion,and two or more fiducial markers, each upper portion having a pair ofbilateral sloping arms connecting the first and second upper portions tothe first and second lower portions, wherein each of the lower portionscomprises a laterally extending foot prong.
 10. The radiographic guidedevice of claim 9, wherein at least one of the pair of bilateral slopingarms comprises an attachment point for a secondary device. 11.radiographic guide device of claim 9, wherein at least one of the lowerportions comprises an attachment point for a secondary device.
 12. Theradiographic guide device of claim 9, wherein the open arched materialdefines an open surgical area that is unimpeded both (a) vertically; and(b) laterally, parallel to the first and second upper portions and abovethe lower portions.
 13. The radiographic guide device of claim 7,further comprising a guide base or a sensor array.
 14. The radiographicguide device of claim 13, comprising a sensor array having two or moresensors, wherein the sensors are positioned at or about at the gumlineof the subject.
 15. The radiographic guide device of claim 14, whereinthe sensors comprise paired sensors.
 16. The radiographic guide deviceof claim 13, comprising a guide base having a guide collar affixed tothe guide base, wherein the guide collar comprises a central openingcoaxially situated with the base opening.
 17. The radiographic guidedevice of claim 7, further comprising two or more fiducial markers. 18.The radiographic guide device of claim 13, wherein the sensor arrayfurther comprises a wireless transponder.
 19. The radiographic guidedevice of claim 7, further comprising a guide base and a sensor array.20. A kit comprising the radiographic guide device of claim 7.